2. System of checks and balances
to ensure product:
Safety
Effectiveness
3. All domestic and foreign
manufacturers of medical devices
intended for sale in the US must
have a quality system
4. A. General provisions
B. Quality System
Requirements, including
Management responsibility,
Quality Audits, and
Personnel requirements
C. Design Controls
D. Document Controls
E. Purchasing Controls
F. Product identification and
traceability at all stages of
production
G. Controlling and defining
production and process,
including validation
5. H. Product Acceptance for
incoming, in-process, and
finished products
I. Controlling nonconforming
product
J. Instituting corrective and
preventive action when errors
occur
K. Labeling and packaging
controls
L. Handling, storage, distribution
and installation
M. Records; including the Device
Master record, Device History
record
N. Servicing
O. Statistical techniques
6. • Plan for investigators to
FO O D A N D DRUG
follow when evaluating a
Medical Device
A DM I N I STRA TI O N
GUIDE TO INSPECTIONS OF manufacturer’s compliance
QUALITY SYSTEMS with Quality Systems
regulations
August 1999
7. Corrective &
Preventive
Design Actions Production &
Controls Process Controls
Management
Material Equipment &
Controls Facility Controls
Records,
Documents, &
Change Controls
8. • QSIT instructs auditors to
focus on four (4) subsystems:
• Management
• Design control
• Corrective and Preventive
Actions
• Production and Process
Control
9. The other subsystems are covered through links
with the four main subsystems:
Records, Documents and Change Control
Throughout ALL the main subsystems
Facility and Equipment Control
Material control
Covered through Production and Process Control
10. A. General provisions
B. Quality System Requirements, including
Management responsibility, Quality Audits,
and Personnel requirements
C. Design Controls
D. Document Controls
E. Purchasing Controls
F. Product identification and traceability at all
stages of production
G. Controlling and defining production and
process, including validation
H. Product Acceptance for incoming, in-process,
and finished products
I. Controlling nonconforming product
J. Instituting corrective and preventive action
when errors occur
K. Labeling and packaging controls
L. Handling, storage, distribution and
installation
M. Records; including the Device Master record,
Device History record
N. Servicing
O. Statistical techniques
12. Quality Policy must exist
Management representative appointed as the
owner and responsible person for the Quality
System
Management reviews of the Quality System take
place
Quality audit procedures
Quality system procedures
Quality audits take place periodically
13. Covers:
Design Controls (820.30)
Production and Process Changes (820.70)
Device Master Record (820.181)
Statistical Techniques (820.250)
14. Design inputs or requirements for device are identified
Design outputs or specifications for device are
identified
Design Review, Verification and Validation
Software validation
Risk analysis
Design transfer to manufacturing completed
successfully
Device Master Record (DMR), and Design History File
(DHF)
15. Design Review
Are the design requirements adequate?
Does the design meet these requirements?
Design Verification
Do the design outputs (specifications) meet the
design inputs (requirements)?
Design Validation
Do the design outputs (specifications) meet the
device’s intended use?
16. Device design must be reviewed throughout
development to ensure all requirements are met
Example:
Design of a portable defibrillator must take into
account factors such as:
• Storage temperatures in an
ambulance
• Shock and vibrations on the
road
• Electromagnetic interference
from communication devices,
other medical equipment,
even the ambulance siren
17. Compilation of records containing all
procedures and specifications for a finished
device
Documents how to perform all specific functions
related to the production of a device
Some examples:
Device Design Specification
Device and part drawings
Manufacturing, Inspection
and Testing procedures
Software
Label artwork
18. One for each device type
Include or refer to all documents that can
demonstrate that the device has been designed
as per an approved design plan
Also include records and results of
Design review
Design verification
Design Validation
Change control
20. CAPA procedures established
Management review of CAPA activities
Data sources (customers, manufacturing, etc.)
analyzed to identify nonconforming product and
quality problems
Statistical analysis across data sources
Investigations conducted to identify root cause of
failures
Nonconforming product controlled, segregated
Appropriate corrective actions and preventive
actions carried out
21. Covers:
Purchasing Controls Receiving, in-process, and
(820.50) finished device acceptance
(820.80)
Identification (820.60)
Acceptance status (820.86)
Traceability (820.65)
Device handling (820.140)
Production and Process
Controls (820.70) Device labeling (820.120)
Inspection, measuring, and Device storage (820.150)
test equipment (820.72)
Device distribution (820.160)
Process Validation (820.75)
Device Installation (820.170)
22. Manufacturing processes validated , controlled
and monitored
Software validated
Equipment is adjusted, calibrated and maintained
periodically
What happens to rejects or nonconforming
product
Production employees trained and qualified
Suppliers must be certified, audited
23. Standard Operating Procedures (SOPs)
Standard Quality Assurance Procedures
(QAPs)
Some examples:
Complaint handling
Maintenance
Calibration
Training
Change Control
Cleaning
Safety
24. All changes or
modifications to a device
must be documented
Manufacturer must
provide documented
evidence of whether a
change alters the device’s
effectiveness or safety
If there are differences in
effectiveness or safety
then the manufacturer
must file a 510(k) or PMA
supplement
25. Company must have a Quality
System in place
FDA audits quality systems based on
subsystems framework
Management involvement is vital
Design, Production, Purchasing,
Equipment, must be in state of
control
Investigate, correct, prevent non-
conformances
Change control
Documentation!
